PARSABIV is a calcium-sensing receptor agonist indicated for:
- Secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. (1)
Parsabiv (etelcalcetide) is considered MEDICALLY NECESSARY when ALL of the following are met:
- The patient has a diagnosis of secondary hyperparathyroidism with chronic kidney disease AND
- The patient is on hemodialysis AND
- The patient’s corrected serum calcium is at or above the lower limit of the normal range AND
- The patient has a pre-treatment or current intact PTH (iPTH) level of greater than or equal to 300 pg/mL AND
- The patient does not have any one of the following limitations to the use of Parsabiv:
ONE of the following:
- Parathyroid carcinoma OR
- Primary hyperparathyroidism AND
- The patient’s medication history includes previous use of a prerequisite agent (Sensipar (cinacalcet) and had an inadequate response to treatment (inadequate reduction in IPTH) OR
- The patient has a documented intolerance, FDA-labeled contraindication, or developed hypocalcemia from treatment
Any other use of Parsabiv(etelcalcetide) is considered INVESTIGATIONAL.
Dosage Forms and Strengths
- Injection: 2.5 mg/0.5 mL solution in a single-dose vial
- Injection: 5 mg/mL solution in a single-dose vial
- Injection: 10 mg/2 mL solution in a single-dose vial
Dosage and Administration
- Ensure corrected serum calcium is at or above the lower limit of normal prior to initiation, dose increase, or re-initiation.
- The recommended starting dose is 5 mg administered by intravenous bolus injection three times per week at the end of hemodialysis treatment.
- The maintenance dose is individualized and determined by titration based on parathyroid hormone (PTH) and corrected serum calcium response. The dose range is 2.5 to 15 mg three times per week.
- The dose may be increased in 2.5 mg or 5 mg increments no more frequently than every 4 weeks.
- Measure serum calcium within 1 week after initiation or dose adjustment and every 4 weeks for maintenance.
- Measure PTH after 4 weeks from initiation or dose adjustment.
- Decrease or temporarily discontinue PARSABIV in individuals with PTH levels below the target range.
- Consider decreasing or temporarily discontinuing PARSABIV or use concomitant therapies to increase corrected serum calcium in patients with a corrected serum calcium below the lower limit of normal but at or above 7.5 mg/dL without symptoms of hypocalcemia.
- Stop PARSABIV and treat hypocalcemia if the corrected serum calcium falls below 7.5 mg/dL or patients report symptoms of hypocalcemia.
- Do not mix or dilute prior to administration.
- Administer by intravenous bolus injection into the venous line of the dialysis circuit at the end of the hemodialysis treatment during rinse back or intravenously after rinse back.
- Parsabiv prescribing information--------. Amgen. April 2017
||Injection, etelcalcetide, 0.1 mg
Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each Policy. They may not be all-inclusive.
This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.
"Current Procedural Terminology © American Medical Association. All Rights Reserved"
History From 2018 Forward
Annual review, no change to policy intent.